NCT06788977Recruiting
External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy
CEFALY Pregnancy Registry
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
This online registry aims to understand the potential benefits and safety of external trigeminal nerve stimulation for the treatment of migraine in pregnant women. Women do not need to use external trigeminal nerve stimulation or any other form of migraine treatment to participate in the registry. The main question it aims to answer is: Is external trigeminal nerve stimulation a safe and effective option for migraine treatment during and after pregnancy? There are no required changes in migraine treatment to participate in this registry. Participants may or may not use external trigeminal nerve stimulation or any other treatment they currently use and may still participate in the registry. There are no clinic or research visits, as the registry is entirely online. Participants will be asked to complete up to six 15- 20-minute surveys over a time period of up to 12 months.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 550 (estimated)
- First submitted
- 27 Nov 2024
- Start date
- 25 Nov 2024
- Primary completion date
- Apr 2027
- Lead sponsor
- Cefaly Technology
- Diseases
- Migraine
- NCT number
- NCT06788977
What you commit to
- Study type: Observational
- Planned participants: 550
- From 25 Nov 2024 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with any other condition which might preclude participation in the opinion of the patient's physician(s) or the study's principal investigator
Age
- Patients under the age of 18 or over the age of 44 at enrollment
Other
- Not pregnant at time of enrollment
- Pregnant with more than one fetus/baby at time of enrollment (multigestational pregnancy)
- No access to email, smartphone, or computer with internet access
Who the study is looking for
- Patients willing and able to provide simple consent for registry participation.
- Has access to email, text messages via smartphone or computer with internet access
- Be between the ages of 18 to 44 years at enrollment.
- Pregnant with one fetus/baby at time of enrollment (singleton pregnancy)
- Have headaches or migraines prior to pregnancy and continued to have headaches or migraines into pregnancy OR headaches or migraines began while pregnant in the first trimester.
- Able to provide proof of active intrauterine pregnancy and estimated due date, via online document upload, using any of the following documents:
- ultrasound report of current pregnancy
- beta hcg lab report
- a signed provider's medical documentation confirming intrauterine pregnancy with fetal heart sounds and estimated due date
- a signed provider's note on a prescription sheet or physician letterhead confirming intrauterine pregnancy and estimated due date
Age in the registry: 18 years to 44 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Darien | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.